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| |  IHC: Botox (botulinum toxin type A) Appears Effective Against Disabling Chronic Migraine, Tension Headache, and Pain of Cervical Dystonia By Larry Schuster ROME, ITALY -- September 24, 2003 -- A 3-year open-label trial of more than 200 patients with disabling, chronic migraine found that botulinum toxin type A (Botox) appeared to significantly reduce the number of headache days, the amount of acute medications consumed and associated disability. Two placebo-controlled studies also found Botox improved pain in patients with cervical dystonia, and that it appeared to offer effective prophylaxis against coexisting migraine and chronic tension-type headache. These studies were presented here September 16th at the 11th Congress of the International Headache Society. In the 3-year open-label trial, Ninan T. Mathew, MD, director, Houston Headache Clinic, Houston, Texas, United States, reported results of Botox treatments on 208 patients, ages 16 to 77, who reported chronic intractable and disabling migraine attacks. Some of the patients had up to 10 sets of Botox treatments, each of about 32 injections in scalp and next sites. "The treatments' effects lasted about 12.5 weeks," Dr. Mathew said. Three months after the initial injection, the mean Migraine Disability Assessment Scores (MIDAS) decreased from 83 to 27, and continued to decrease after the second and third treatments, where it stabilized in the range of 10.2 and 15.7. The mean number of headache days decreased from about 67 to 29 after 3 months of treatment. Also, in 88 patients taking triptans, the mean number of tablets consumed decreased from about 16 per month before treatment, to 4.2 tablets after treatment. Use of nonsteroidal anti-inflammatory drugs, isometheptene or ergotamine also decreased significantly after Botox therapy. Dr. Mathew said about 65% to 70% of patients respond to this treatment. "We're trying to identify why some patients respond and some don't." The study results expand on a report presented in 2002 when Dr. Mathew's group reported on almost half as many patients. In this most recent study, he concluded, "Long-term, continued benefit speaks against placebo effect." Large-scale, placebo-controlled trials in patients with chronic headaches are needed to confirm this conclusion. Such a trial is underway, with results not due for another year. The second study presented, by Mitchell Brin, MD, of Allergan Inc, Irvine, California, United States, maker of Botox, and Allison Brashear, MD, Indiana University Hospital, Indianapolis, Indiana, United States, was a double-blind placebo-controlled randomised study of Botox for management of pain in 170 patients with cervical dystonia (CD). The results showed that after 6 weeks of treatment, 29.5% of Botox patients achieved at least one grade decrease in pain compared to 12.5% of placebo patients. About 32% of Botox patients achieved one grade decrease in pain intensity compared to 6.9% in the placebo group. A third double-blind, placebo controlled study, presented by Hartmut Gobel, of the Kiel Pain Clinic, Germany, included 40 patients with migraine and tension-type headache. The study found that the average number of days with migraine and tension-type headache decreased significantly compared to placebo. In the first month after treatment, researchers observed a 41.6% decrease in the number of migraine days, while for the placebo group, the number of migraine days increased by 5.6%. Botox reduced by 19.3% the number of tension-type headache days 1 month after treatment, compared to an increase of 2.4% with placebo. New research released at the meeting also indicates the Botox injections are not just relaxing muscles. K. Roger Aoki and Minglei Cui, both of Allergan, reported the results of animal experiments, which found that "inhibition of nociceptive processing at the peripheral site and at the spinal cord level may underline the mechanism of Botox's effects in alleviating pain conditions." The studies were released just as research published for the first time describes the procedure for administering the toxin in patients with migraine and tension-type headache. The report appeared in the September 2003 edition of Headache: The Journal of Head and Face Pain. First author Andrew M. Blumenfeld, MD, Southern California Permanente Medical Group, San Diego, California, Unites States, said he hopes the article leads to standardizing the practice of Botox therapy for headaches. Currently, Dr. Blumenfeld said, there is no standard, and the drug is being administered in a wide range of methods, and that variation may account for reports that were less than satisfactory. All researchers said it is important that only physicians who are experienced in its use administer Botox.
[Study titles: Treatment of Coexisting Migraine and Chronic Tension-Type Headache in botulinum A. Abstracts P5N5; Effect of botulinum toxin type A Therapy on Pain Frequency and Intensity in Patients with Cervical Dystonia. Abstract P6R19; Botulinum toxin type A Modified Chronic Migraine; Further Long-Term Evidence. Abstract P5N38]
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